Vaccine Therapy in Treating Patients With Liver Cancer
A Phase I/II Trial Testing Immunization With Dendritic Cells Pulsed With Four AFP Peptides in Patients With Hepatocellular Carcinoma
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have liver cancer.
Studieoversigt
Detaljeret beskrivelse
OBJECTIVES:
- Determine the maximum tolerated dose of alpha-fetoprotein peptide-pulsed autologous dendritic cells in HLA-A*0201-positive patients with hepatocellular carcinoma.
- Determine the safety and toxicity of this regimen in these patients.
- Determine the immunological effects of this regimen in these patients.
- Determine the progression-free survival and clinical responses in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive alpha-fetoprotein peptide-pulsed autologous dendritic cells intradermally on day 1. Treatment repeats every 2 weeks for a total of 3 doses in the absence of unacceptable toxicity.
Cohorts of 3-12 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 12 patients experience dose-limiting toxicity.
Patients are followed at weeks 1, 4, and 12 and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- HLA-A*0201 positive adults over the age of 18.
- Have HCC with a serum AFP determination >30ng/ml.
- Both male and female patients may be enrolled.
- Karnofsky Performance Status greater than or equal to 70 percent.
- No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.
- No previous evidence of opportunistic infection.
Adequate baseline hematological function as assessed by the following laboratory values with 30 days prior to study entry:
- Hemoglobin >9.0g/dl
- Platelets >50000/mm3
- Absolute Neutrophil Count >1,000/mm3
- Child-Pugh Class A or B for chronic liver disease.
- Ability to give informed consent.
Exclusion Criteria:
- Any congenital or acquired condition leading to inability to generate an immune response, including concomitant immune suppressive therapy.
- Concomitant steroid therapy or chemotherapy, or any of these other treatments < 30 days before the first vaccination.
- Females of child-bearing potential must have negative serum beta-HCG pregnancy test (within Day -14 to Day 0).
- Acute infection: any acute viral, bacterial, or fungal infection, which requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.
- HIV-infected patients.
- Patients with any underlying conditions which would contraindicate therapy with study treatment.
- Patients with organ allografts.
- O2 sat <91% on room air; dyspnea at rest.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Treatment
See intervention description.
|
Increasing doses of AFP will be given to groups of 3 intradermally.
Subjects will receive 3 biweekly vaccinations.
At least 2 patients at a given dose must have received their complete 3 vaccination schedule with a 30 day observation period after the last vaccination before a higher dose is initiated.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Dose limiting toxicity and maximum tolerable dose.
Tidsramme: 1 year
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1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Generation of AFP specific immunity.
Tidsramme: 3 years
|
3 years
|
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Progression-free survival.
Tidsramme: 3 years
|
3 years
|
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clinical response in patients with measurable disease.
Tidsramme: 3 years
|
3 years
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: James S. Economou, MD, Jonsson Comprehensive Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000068806
- UCLA-0001026
- NCI-G01-1997
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